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SR-XRPD Applications

X-Ray Powder Diffraction (XRPD) is a powerful technique that uses the diffraction of X-rays on powder or microcrystalline samples for structural characterization. The use of synchrotron radiation (SR-XRPD) allows:

  • An improved indexing and structure solution
  • A substantial lower level of detection of mixture components (< 0.05 % wt)
  • Very fast measurements (msec), ideal for kinetic analyses

 

Typical applications of SR-XRPD include:

  • Structural solution of the solid form of new molecular entities during screening and selection processes 
  • Development of formulation and screening of excipients, including co-crystals 
  • Quality-by-design (QbD) approach for drug development 
  • Patent application for new materials and patent-life extension 
  • Characterization and high-accuracy quantification of all polymorphic forms in a drug substance and drug product, including in fully opaque blisters and in the presence of crystalline excipients. 
  • Detection of impurities down to a trace level (< 0.05% wt) 
  • Bi-dimensional distribution of drug substance polymorphs and excipients in a tablet 
  • Optimization of manufacturing processes, in particular crystallization, formulation, drying, lyophilization, wet granulation, tabletting and packaging operations. 
  • In situ non-ambient kinetic studies at milli-sec scale. 
  • Stability studies of polymorphic forms 
  • Continued Process Verification, in order to "maintain the process in a state of control over the life of the process" and "to continually improve [the] process", by performing "process improvement and innovation through sound science", as required by the new FDA guidance on process validation (FDA, 2011) 
  • Comparability studies following process changes or technology transfers 
  • Troubleshooting activities and investigations during commercial manufacturing 
  • Detection of counterfeits even with minute differences

 

More information on the applications for SR-XRPD can be found here.

 
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